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Kogenate Fs Generic Name & Formulations
Legal Class
Rx
General Description
Antihemophilic Factor VIII (recombinant) 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU; per vial; lyophilized pwd for IV infusion after reconstitution; contains sucrose; preservative-free.
Pharmacological Class
Clotting factor.
How Supplied
Kit—1 (vial w. diluent and BIO-SET system)
Manufacturer
Kogenate Fs Indications
Indications
Prevention and control of hemorrhagic episodes in Hemophilia A. Surgical prophylaxis in Hemophilia A. Routine prophylaxis to reduce frequency of hemorrhagic episodes and joint damage in children with Hemophilia A with no pre-existing joint damage.
Kogenate Fs Dosage and Administration
Adults and Children
Dosage Required (IU) = Body Weight (kg) × Desired % Factor VIII Increase × 0.5. Individualize. Infuse over 1–15mins if tolerated. Minor hemorrhage: 10–20 IU/kg; may repeat dose if needed. Moderate hemorrhage or minor surgery: 15–30 IU/kg; may repeat dose every 12–24hrs until resolved. Major hemorrhage, fractures or head trauma: initially 40–50 IU/kg, then 20–25 IU/kg every 8–12hrs until resolved. Major surgery: pre-op: 50 IU/kg (verify 100% activity prior to surgery); repeat if needed after 6–12hrs initially, and for 10–14 days until completely healed. Routine prophylaxis in children: 25 IU/kg every other day.
Kogenate Fs Contraindications
Contraindications
Mouse or hamster protein sensitivity.
Kogenate Fs Boxed Warnings
Not Applicable
Kogenate Fs Warnings/Precautions
Warnings/Precautions
Not for von Willebrand's disease. Confirm Factor VIII deficiency prior to treatment. Monitor for development of Factor VIII inhibitors. Labor & delivery. Pregnancy (Cat.C). Nursing mothers.
Kogenate Fs Pharmacokinetics
See Literature
Kogenate Fs Interactions
Not Applicable
Kogenate Fs Adverse Reactions
Adverse Reactions
Inj site reactions, dizziness, rash, BP increase, pruritus, hypersensitivity reactions, antibody formation, central venous line-associated infections.
Kogenate Fs Clinical Trials
See Literature
Kogenate Fs Note
Not Applicable
Kogenate Fs Patient Counseling
See Literature
